NCT05149027

A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combine With Toripalimab in Patients With Advanced HCC and Other Solid Tumors

An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced HCC and Other Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1 dose confirmation and Part 2 dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with Toripalimab in patients with advanced HCC and other solid tumors.

Detailed description

subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first. This trial consists of : * A screening period: 28 days * A treatment period: * Part 1 dose confirmation study * Part 2 dose expansion study * A post-treatment follow-up period, including * A safety follow-up period: 28 days after the last dose of study drug; * Post-treatment follow-up visit: day 84 after the last dose of study drug; * Survival follow-up.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	HBM4003 and Triprilimab	Subjects will be treated with HBM4003 and Toripalimap on Day 1 during each 21-day cycles.

Timeline

• Start date: 2021-12-20
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2021-12-08
• Last updated: 2021-12-08